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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190610
Device Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A biomedical technician (biomed) at a user facility reported that a fresenius 2008k2 hemodialysis (hd) machine had no power and the rocker switch was melted. Technical support recommended replacing the power switch. The melted rocker switch and a discolored power cord were noticed after patient treatment. The machine was powered off then would not power back on. A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction. The machine has approximately 9,000 hours and the rocker switch and power cord were the original fresenius parts on the machine. The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the discolored power cord and melted rocker switch. The machine has not had any past problems with failing the electrical leakage test. The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. The biomed ordered a replacement power cord and rocker switch and will replace once received. The unit has not been returned to service at this time. The original rocker switch and power cord are available to be returned to the manufacturer for physical evaluation.
 
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Brand Name2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key12704676
MDR Text Key278585575
Report Number2937457-2021-02156
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup,Followup
Report Date 02/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number190610
Device Catalogue Number190610
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2021
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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